Autism Clinical Trial
— TAASDOfficial title:
3/3 Treatment of Anxiety in Autism Spectrum Disorder
Anxiety disorders affect 40 to 50% of children with autism spectrum disorders (ASD), contributing to substantial distress and impairment. The goal of this study is to examine the effectiveness of a personalized type of psychotherapy against standard-care psychotherapy for addressing anxiety in youth with ASD.
Status | Recruiting |
Enrollment | 201 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Years to 13 Years |
Eligibility |
Inclusion Criteria: - Outpatient boys and girls with ASD between the ages 8-13 years at consent/assent. - The child meets criteria for ASD. - The child meets criteria for clinically significant anxiety symptoms. - The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70 as assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable Intelligence Quotient test. Exclusion Criteria: - Receiving concurrent therapy targeting anxiety, social skills training with homework, or behavioral interventions (e.g., applied behavior analysis). This excludes academic tutoring, occupational therapy, speech therapy, school counseling that is no more than 60 minutes per week in duration, school aides, and social skills training groups that do not include homework and are no more than 60 minutes/week in duration. - (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention. - Child has been nonresponsive to an adequate trial of CBT for anxiety within the previous 2 years. - Lifetime bipolar disorder, schizophrenia or schizoaffective disorder. - Initiation of an antidepressant medication within 12 weeks before study enrollment or an antipsychotic medication 6 weeks before study enrollment or the child has changed the dose of an established medication within 8 weeks before study enrollment (4 weeks for antipsychotic) or during psychotherapy (unless the dose is lowered because of side effects). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Temple University Child and Adolescent Anxiety Disorders Clinic | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, University of South Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in anxiety severity on the Pediatric Anxiety Rating Scale after 16 weeks of treatment | This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety. | After 16 weeks of treatment | No |
Secondary | Change from Baseline in anxiety severity on the Clinical Global Impressions Scale after 16 weeks of treatment. | This measure is completed by the clinician and assesses the severity of anxiety on a 7 point scale (1-7; higher scores correspond to worse anxiety). | After 16 weeks of treatment | No |
Secondary | Change from Baseline in anxiety severity on the Child and Adolescent Symptom Inventory after 16 weeks of treatment. | This questionnaire is completed by parents and will be used to assess anxiety with higher scores representing worse anxiety. | After 16 weeks of treatment | No |
Secondary | Change from Baseline in anxiety related impairment as measured by the Childhood Anxiety Impact Scale after 16 weeks of treatment. | The Childhood Anxiety Impact Scale is a questionnaire completed by parents about the impact of the child's anxiety on functioning in certain situations. Higher scores correspond to more associated impact. | After 16 weeks of treatment | No |
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